Z-1531-2021 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- March 15, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95,042 pacemakers [updated 03/20/2023]
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution: U.S (nationwide) to states including.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.( countries): [806 Amendment - after March 2021 - updated 3/20/2023] Algeria, Angola, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Benin, Bolivia, Brazil, Bulgaria, Cameroon, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Korea, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Palestine, Panama, Paraguay, Peru Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Servia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.